HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to explore biomarker development in patients with newly diagnosed Head and neck squamous cell carcinoma (HNSCC) receiving curative therapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age \>/= 18 years
• Histologically proven Head and Neck Squamous Cell carcinoma
• Primary or nodal disease \> 3cm for biomarker imaging
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Planned for curative surgery or (chemo)radiotherapy
• Willingness to undergo repeat MRI imaging
• Able to receive and understand verbal and written information regarding study and able to give written informed consent
• Adequate renal function: Calculated creatinine clearance \>/= 30ml/min
• Be able to lie comfortably on back for 1 hour
Locations
Other Locations
Canada
Princess Margaret Cancer Center
RECRUITING
Toronto
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2027-01-15
Participants
Target number of participants: 60
Treatments
Other: Cohort A
Participants who are to receive standard of care radiotherapy will have one biopsy and MRI scan before starting radiotherapy and during week two of radiotherapy. Participants will also have an the option to consent to an additional biopsy and MRI scan during week 4 of radiotherapy. Oral pimonidazole will be taken the night before each biopsy.
Other: Cohort B
Participants who are to receive standard of care curative surgery will have an MRI scan within one week prior to surgery. Tumor tissue from the surgery will also be collected for research. Oral pimonidazole will be taken the night before surgery.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto